Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title: A Phase II Randomized Study of 2 Stereotactic Body Radiation Therapy (SBRT) Regimens for Medically Inoperable Patients With Node Negative, Peripheral Non-Small Cell Lung Cancer

Status Completed

Clinical Trial Summary

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known which regimen of radiation therapy is more effective in treating patients with non-small cell lung cancer.

PURPOSE: This randomized phase II trial is studying the side effects of two radiation therapy regimens and to see how well they work in treating patients with stage I or stage II non-small cell lung cancer.

Clinical Trial Description

OBJECTIVES:

Primary

• To compare the incidence of toxicity with two established stereotactic body radiotherapy (SBRT) regimens in patients with node-negative, peripheral stage I or II non-small cell lung cancer.

Secondary

• To compare quality of life, patterns of failure, disease-free survival, and overall survival of these patients after treatment with one of two established SBRT regimens.

• To correlate outcomes and toxicities with imaging and patient and tumor biomarkers.

OUTLINE: Patients are stratified according to Karnofsky performance status and treatment center. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo 1 high-dose fraction of stereotactic body radiotherapy (SBRT).

• Arm II: Patients undergo 3 high-dose fractions (approximately 1 week apart) of SBRT.

Quality of life is assessed periodically by the EORTC QLQ-C30 and -LC13 questionnaires

Blood and tissue samples may be collected periodically and examined for biomarkers via ELISA and immunoblotting.

After completion of study treatment, patients are followed for 5 years. ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

• NCT number: NCT00843726
• Study type: Interventional
• Source: Roswell Park Cancer Institute
• Status: Completed
• Phase: Phase 2
• Start date: September 12, 2008
• Completion date: May 6, 2020